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Gen2

FDA UDI

Class I (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name
GEN2 FDA UDI
Generic Name
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI
Device Name
ROCHESTER PEAN FORCEPS, 12'', CVD FDA UDI
Model / Reference
G2G1081 FDA UDI
Description
ROCHESTER PEAN FORCEPS, 12'', CVD FDA UDI

Identifiers

Catalog Number
G2G1801 FDA UDI
Primary DI / UDI-DI
00840343722463 FDA UDI
FDA Product Code
GEN FDA UDI
GMDN Term
Surgical soft-tissue manipulation forceps, scissors-like, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 12 Inch FDA UDI

Category: Surgical soft-tissue manipulation forceps, scissors-like, reusable

Gen2 by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical soft-tissue manipulation forceps, scissors-like, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgix Medical Llc

Sources (1)

  • FDA UDI bb9977b3-4715-4bab-bad5-d94ea4741f3c 36 fields · synced May 30, 2026